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A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AMG 557
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of SLE with positive ANA
  • Stable disease with no change in SLE therapy within the previous 30 days
  • BMI from 18 to 38 kg/m2

Exclusion Criteria:

  • Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
  • Evidence of renal disease or liver disease
  • Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
  • Prior administration of any other biologic that primarily targets the immune system

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMG 557

Placebo

Arm Description

AMG 557 administered as subcutaneous and intravenous doses.

No active drug

Outcomes

Primary Outcome Measures

Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs

Secondary Outcome Measures

Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
Serum concentration and derived PK parameters including Tmax, AUClast and Cmax

Full Information

First Posted
January 6, 2015
Last Updated
March 27, 2015
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02391259
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
Official Title
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG 557
Arm Type
Experimental
Arm Description
AMG 557 administered as subcutaneous and intravenous doses.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No active drug
Intervention Type
Drug
Intervention Name(s)
AMG 557
Intervention Description
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
contains no active drug
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
Time Frame
From 29 days to 169 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
Description
Serum concentration and derived PK parameters including Tmax, AUClast and Cmax
Time Frame
From 29 days to 169 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of SLE with positive ANA Stable disease with no change in SLE therapy within the previous 30 days BMI from 18 to 38 kg/m2 Exclusion Criteria: Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization Evidence of renal disease or liver disease Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis Prior administration of any other biologic that primarily targets the immune system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Research Site
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Research Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Research Site
City
London
ZIP/Postal Code
NW10 7NS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27099766
Citation
Sullivan BA, Tsuji W, Kivitz A, Peng J, Arnold GE, Boedigheimer MJ, Chiu K, Green CL, Kaliyaperumal A, Wang C, Ferbas J, Chung JB. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016 Apr 8;3(1):e000146. doi: 10.1136/lupus-2016-000146. eCollection 2016.
Results Reference
derived
PubMed Identifier
26138472
Citation
Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB. Blockade of interferon-gamma normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

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